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For Companies At a Glance
- Tasks: Ensure quality assurance in biotech manufacturing and support compliance activities.
- Company: Vertex Pharmaceuticals, a leader in transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Why this job: Join a pioneering team making a real difference in healthcare.
- Qualifications: Degree in biotech/life sciences and experience in GMP operations.
- Other info: Dynamic role with potential for impactful contributions in a global company.
The predicted salary is between 48000 - 72000 £ per year.
Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid, 3 days on site in Paddington, London.
Department: Operational Area Quality
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
General Summary
This role is recognized as an expert internally in the principles and application of quality assurance and compliance. The person will provide QA support for manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will be primarily focused on batch record review, archival & support activities related to product disposition activities.
Key Duties & Responsibilities
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Support in archiving activities.
- Support QA execution of process and OOS investigations, and associated CAPAs.
- Support for approval of COAs and product labelling.
- Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
- Support GMP release of incoming raw material and components.
- Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
- Responsible for identifying compliance risks and gaps for GMP processes.
- Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting.
- Support Cell & Genetic Program and Quality projects including Quality system, and manufacturing process/SOP improvements.
Required Knowledge/Skills
- Bachelor's degree in biotech/life sciences field.
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
- Demonstrated experience in batch review/batch disposition of sterile products, biologic products and/or ATMPs.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA.
- Experience with network-based applications such as Oracle, TrackWise, Veeva.
- Understanding of regulatory environment including quality systems and compliance.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach.
- Ability to facilitate cross-functional meetings/projects and effectively communicate with business stakeholders.
- Critical Thinking and Problem-Solving skills.
GMP Operational Quality Senior Specialist in London employer: Talent Works
Contact Detail:
Talent Works Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Operational Quality Senior Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the biotech and life sciences field, especially those who work at Vertex or similar companies. A friendly chat can open doors and give you insider info on job opportunities.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and compliance standards. We recommend practising common interview questions related to quality assurance and having examples ready that showcase your experience in batch review and investigations.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar as they make their decision.
✨Tip Number 4
Apply through our website for the best chance of landing that GMP Operational Quality Senior Specialist role. We’ve got all the latest openings, and applying directly shows your commitment to joining the team!
We think you need these skills to ace GMP Operational Quality Senior Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the GMP Operational Quality Senior Specialist role. Highlight your relevant experience in quality assurance and compliance, especially in batch record review and GMP processes. We want to see how your skills align with what Vertex is looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background makes you a perfect fit. Don’t forget to mention your experience with regulatory environments and any specific tools like Oracle or TrackWise that you’ve used.
Showcase Your Problem-Solving Skills: Vertex values critical thinking and problem-solving abilities. In your application, share examples of how you've successfully led investigations or resolved compliance issues in the past. We love seeing how you tackle challenges head-on!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets noticed by the right people at Vertex. Plus, it shows you’re serious about joining the team!
How to prepare for a job interview at Talent Works
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Understand the principles and applications of quality assurance and compliance, especially as they relate to batch record review and product disposition. Being able to discuss specific examples from your experience will show that you're not just familiar with the concepts but can apply them effectively.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate your problem-solving skills, particularly in relation to event investigations and CAPA. Think of real-life scenarios where you've successfully led investigations or resolved compliance issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Familiarise Yourself with Relevant Software
Since the role involves using network-based applications like Oracle, TrackWise, and Veeva, it’s a good idea to get comfortable with these tools. If you have experience with them, be ready to discuss how you’ve used them in past roles. If not, do a bit of research to understand their functionalities and how they relate to quality assurance processes.
✨Show Your Communication Skills
This position requires effective communication with various stakeholders. Be prepared to discuss how you've facilitated cross-functional meetings or projects in the past. Highlight your ability to convey complex information clearly and how you’ve built relationships across teams to drive compliance and quality initiatives.
